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DRUG DESCRIPTION :
desogestrel & ethinyl estradiol Tablets are a triphasic oral
contraceptive containing two active components, desogestrel and
ethinyl estradiol. Each 28-day treatment cycle pack consists of
three active dosing phases: 7 light yellow tablets containing
0.100 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17α
-pregn-4-en-20-yn-17-ol) and 0.025 mg ethinyl estradiol
(19-nor-17α -pregna-1,3,5(10)-trien-20-yne-3, 17-diol); 7 orange
tablets containing 0.125 mg desogestrel and 0.025 mg ethinyl
estradiol, and 7 red tablets containing 0.150 mg desogestrel and
0.025 mg ethinyl estradiol. Inactive ingredients include vitamin
E, pregelatinized starch, stearic acid, lactose monohydrate,
hydroxypropyl methylcellulose, polyethylene glycol, titanium
dioxide, talc, yellow ferric oxide (in light yellow and orange
tablets), and red ferric oxide (in orange and red tablets). also
contains 7 green tablets with the following inert ingredients:
lactose monohydrate, corn starch, magnesium stearate,
hydroxypropyl methylcellulose, polyethylene glycol, titanium
dioxide, FD&C Blue No. 2 aluminum lake, yellow ferric oxide, and
talc. The molecular weights for desogestrel and ethinyl estradiol
are 310.48 and 296.40, respectively. The structural formulas are
as follows:
INDICATIONS :
desogestrel / ethinyl estradiol Tablets are
indicated for the prevention of pregnancy in women who elect to
use this product as a method of contraception
DOSAGE AND ADMINISTRATION :
To achieve maximum contraceptive effectiveness, (desogestrel/ethinyl
estradiol) Tablets must be taken exactly as directed, at the same
time every day, and at intervals not exceeding 24 hours.
desogestrel/ethinyl estradiol may be initiated using either a
Sunday start or a Day 1 start.
NOTE: Each cycle pack dispenser is preprinted with the days of the
week, starting with Sunday, to facilitate a Sunday start regimen.
Six different “day label strips” are provided with each cycle pack
dispenser in order to accommodate a Day 1 start regimen. In this
case, the patient should place the self-adhesive “day label strip”
that corresponds to her starting day over the preprinted days.
SIDE
EFFECTS :
An increased risk of the following serious adverse reactions has
been associated with the use of oral contraceptives (see
WARNINGS):
* Thrombophlebitis and venous
* thrombosis with or without embolism
* Arterial thromboembolism
* Pulmonary embolism
* Myocardial infarction
* Cerebral hemorrhage
* Cerebral thrombosis
* Hypertension
* Gallbladder disease
* Hepatic adenomas or
* benign liver tumors
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